ClearPoint Neuro, Inc. (CLPT) Q1 2018 Earnings Report, Transcript and Summary

Greetings, and welcome to the MRI Interventions' 2018 First Quarter Financial Results Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions]. As a reminder, this conference is being recorded. The comments made on this call may include statements that are forward-looking within the meaning of Securities Laws. These forward-looking statements may include without limitation statements related to anticipated industry trends, the Company's plans, prospects, and strategies both preliminary and projected and management's expectations, beliefs, estimates, or projections regarding future results of operations. Actual results or trends could differ materially. The Company undertakes no obligation to revise forward-looking statements for new information or future events. For more information, please refer to the Company's Annual Report on Form 10-K for the year ended December 31, 2017, and the Company's Quarterly Report on Form 10-Q for the three ended March 31, 2018 both of which have been filed with the Securities and Exchange Commission. All the Company's filings may be obtained from the SEC or the Company's website at www.mriinterventions.com. It is now my pleasure to introduce your host Joe Burnett, CEO.

Thank you Roya and good afternoon everyone. Thanks for joining us for the first quarter 2018 earnings call. With me for today's call is Hal Hurwitz, our CFO. It has been an exciting few months at MRI Interventions including the number of structural and strategic changes designed to expand our future growth opportunities, earn MRI a greater share of revenues from the procedures, our ClearPoint Neuro Navigation System guides and open new opportunities to better leverage our world class team. I am going to briefly turn the call over to Hal to summarize the financial results released earlier today, then I will come back on the line to discuss a few aspects of the quarter and our progress on the four key strategic pillars we announced on our last conference call including the concurrent press release about our new strategic agreement with Voyager. After that we will open up the call for Q&A. Hal.

Thank you Joe. For the first quarter ended March 31, 2018 total revenues were $1.6 million compared with $1.6 million for the fourth quarter and $2 million for the same period in 2017. Breaking that down a bit to the underlying product areas, in functional neurology product sales decreased 11% to $1.1 million compared with $1.3 million for the same period in 2017. We completed 160 ClearPoint procedures in the first quarter 2018, level to the preceding quarter and up 11% year-over-year. The difference in revenue largely reflected the mix between single kit and double kit cases and some stocking orders from larger sites in the prior year first quarter. Capital equipment revenue was $263,000 for the first quarter down 23% from $344,000 for the same period in the prior year. Capital equipment fluctuation quarter-to-quarter, we have seen a delay on two system sales related to uncertainty about laser ablation probs. Biologic and drug delivery revenue was $211,000 down 43% year-over-year due to two large orders placed in the first quarter of 2017 that totaled $305,000 versus $74,000 in the current year's first quarter. The company has altered its business practices to encourage customers to take delivery in smaller quantities against open purchase orders rather than bulk purchases in single quarters in an effort to smooth this portion of our revenue and better reflect case utilization in our drug delivery partnerships. Gross margin for the 2018 first quarter was 64% compared to gross margin of 63% for the same period in 2017. The increase in gross margin primarily reflected a favorable mix of products sold. Research and development costs were $546,000 during the 2018 first quarter compared to $558,000 during the same period in 2017. Sales and marketing expenses declined to $962,000 for the 2018 first quarter compared to $1.1 million for the same period in 2017, a decrease of 10%. General and administrative expenses were also down at $953,000 for the first quarter 2018 compared with $984,000 for the first quarter of 2017. Our loss from operations for the 2018 first quarter was $1.4 million up only about 5% year-over-year. Turning briefly to the balance sheet, during the 2018 first quarter cash used in operating activities was $2 million as compared to $1.3 million in the fourth quarter. This increase in burn over the preceding quarter was due to annual bonus payments and one time payments primarily related to personnel. With that I will now turn the call back to Joe.

Thanks Hal. As you can see the first quarter represented the reset for MRIC as we redefined our growth strategies and set baselines for accountability going forward. As many of you recall on our last report I introduced a reorganization of our corporate strategy and vision to center around four priorities over the next five years. Those were number one, focusing on new efforts to grow our core functional neurosurgery business for deep brain stimulation, laser ablation, and tumor biopsy; number two, leveraging our leadership in live image guidance for precision delivery of biologics and drugs to key and often deep structures of the brain; number three, launching our own new therapy products starting with our precision guided neuro aspiration therapy device in collaboration with the Mayo Clinic; and number four, scaling our business model to both expand globally and better monetize our established sales channel to distribute additional products and services. We believe these four pillars expand our addressable market to more than $1 billion of total opportunity. Our ClearPoint System remains at the center of our platform as the hub enabling surgeons and hospitals to perform different types of procedures relying on ClearPoint accuracy for guidance. These indications including deep brain stimulation, tumor biopsy, laser ablation, and guided aspiration will make up the spokes of the hub and spoke model each relying on different disposable devices, software, and workflows for the most precise and efficient approach possible. We expect that disposable devices will continue to make up more than 80% of our overall revenue staying true to our razor razorblade model. We will also stick to our strengths and focus our commercial efforts today in neurosurgery. I have now taken on direct leadership of our sales and marketing teams to ensure our commercial efforts have the clear and unarguable attention of our Executive Team and the best use of our resources. We are working on new programs to drive higher utilization and reduce barriers to scheduling ClearPoint procedures. An example that I detailed on our last call is the best practices initiative designed to identify all the workflow improvements that can be made to reduce procedure time and in turn enable two procedures a day instead of one. This first presentation of these tools will be made at the Association of Functional Neurosurgery Congress held in Denver this June. That effort focuses on systematically analyzing the practices of our proven high volume centers and then rolling those same protocols out to other sites that have the same equipment and opportunities but are simply doing fewer cases today. We believe this effort can have the same effect as adding a large number of sites simply by working with our existing centers to drive more ClearPoint utilization which in turn we believe adds economic advantages to those centers. We have also adopted new sales forecasting methodologies that are more closely tracking cases. In particular we are addressing cases that do not go to completion in order to correct the underlying issues and work with our hospital site partners to ensure they treat every ClearPoint case available. As it relates to our Q1 performance we did achieve year-over-year growth with 160 ClearPoint cases. However, we missed our internal target by 10 cases in Q1. Importantly we know where each and every missed case came from. We missed six cases due to the Northeastern blizzard that hit the first two weeks in January when patients were unable to make it to the hospital, we lost five cases in the Midwest where a single hospital was evaluating the Abbot [ph] St. Jude deep brain stimulation system, and because that system does not yet have an indication for MRI compatibility the site decided to perform those cases in the operating room instead of the MRI suite. Plus they did not use our system. We postponed an additional five cases because of a holiday that was planned by one of our super users that our sales team was not aware of at the time and we missed an additional two cases in Q1 as a result of questions surrounding the FDA letters or warning letters surrounding laser ablation which at present are still yet not resolved. As it relates specifically to laser ablation procedures it is important to walk through the past and potential impact. The two warning letters for laser procedures focused around unwanted heating of the ablation probe from Monteris's system and potential temperature monitoring inaccuracies for laser ablation thermometery in general. In the past seven weeks we have seen eight cases that have been taken off the schedule as a direct result of the FDA warning letters in this space which represents about 20% to 25% of our total laser ablation procedures during that time. The impact to our business can be characterized in two ways; first, cases that are taken off the schedule we view as disposable revenue at existing sites that is simply pushed out. To be clear these patients are still sick and in many cases were targeted for laser ablation because open surgery was not viewed as a good option for them. We believe we will have this opportunity to make up many of the cases in the future when any of the outstanding issues have been resolved. In the case of Monteris we expect that resolution to take place in Q3 or Q4 of this year which at current run rates could mean an additional 20 to 35 cases that may be postponed. As a reminder from our profitability standpoint these laser ablation cases are some of the least profitable for our company as they involve typically a single smart frame device and none of our smart flow cannulas. So while we would rather not lose a single case, if we were ever going to lose cases laser ablation are the least impactful to our bottom line. Second, we have seen our capital sales number impacted as two ClearPoint System sales that we expected to close by now are still on hold as they are in joint acquisition processes with laser manufacturers. Again we view these not as losses but rather postponements. We believe laser ablation is an important tool and essential for hospitals who want to provide their patients with any and all surgical options. As these improvements come out in the second half of 2018, we expect these capital sale deals to continue to progress through the process. To offer some of my own perspective when I've seen similar instances of FDA concerns in cardiology around drug eluding stents and peripheral vascular therapies, the common theme that ends up front of mind for doctors and hospitals can be summarized as we need to be more careful. In my prior life at Volcano these were opportunities for guidance technologies like IFS [ph] and FRR to help hospitals to be more careful by using better and more precise guidance tools. We will turn this into an opportunity for our company as well because ClearPoint is a perfect tool to make -- to more precisely guide laser probe placement and be as careful and precise as possible. Moving to our second pillar, we are shifting to become a more proactive leader in biologics and drug delivery. We are involved with a number of leading partners conducting clinical studies, a role where our live guidance and drug delivery cannulas are critical to the trial structure. But it is an area where we have historically been reactive rather than proactive. We intend to change that and have initiated evaluations of both ClearPoint and our drug delivery cannulas with three additional potential partners for inclusion in future pre-clinical and clinical work. And will be identified in building relationships with others. We also continued progress toward obtaining CE Mark for our SmartFlow cannula and have identified internal resources who will actively focus on the growth of this exciting part of our business. As you may have seen in the subsequent release today we announced a strategic agreement with Voyager to provide supply, joint development, and clinical services for their Phase 2 and Phase 3 programs for Parkinson's disease. This is a perfect example of the vision that we have as a partner in biologics and drug delivery to become the device partner for biologic therapy companies to deliver their vector to precise and often deep structures of the brain. New activities as part of this agreement will commence immediately and we are very excited about our joint collaboration and the benefit we will have on the patients with Parkinson's disease in the future. Turning to our third pillar, our expansion into therapy, we continue to make good progress in collaboration with the Mayo Clinic for the development of what we believe will be a first of its kind neuro aspiration device. We are planning to submit a 510-K with the FDA in the third quarter of 2018 and commence first in human cases before the end of the year. If our mantra for our historical business is to help physicians decide, guide, and confirm the procedure our pending play into therapies will make us the company that can decide, guide, treat, and confirm and own a greater part of the procedure and gain greater financial leverage by providing both guidance and therapy with our same deployed sales team in a single procedure. Finally with regard to achieving global scale we've had discussions with prospective customers in three countries outside of the U.S. We expect these conversations to continue to help us prioritize targets and resources during the second half of 2018 and lead to placements and support outside the U.S. in 2019. Meanwhile we are focused on more efficiently deploying our resources as seen by the 10% reduction in sales and marketing spend year-over-year and a 100 basis point increase in gross margin despite the lower revenue. I continue to be immensely impressed with our talented clinical specialist team and their ability to provide both case support and essential marketing and product development tasks and leadership during their non surgery time. You never have a single job description when working at a small company and across the Board each and every specialist continues to step up and take on more responsibility at this important time for the company. In summary we believe execution against these four growth drivers will set the table for MRI to become the premier live guidance therapy company in the neurosurgery space. With that I will turn the call over to the operator for our questions-and-answer session.

[Operator Instructions]. Thank you. Our first question comes from the line of Kris Tuttle with SoundView Technology Group. Please proceed.

Hey guys, thanks for taking my question. I just got a couple right off the back, could you provide some more color on what the timing of the Voyager shipments are going to be, congratulations on the agreement, it is terrific and just curious to know is that Q2, Q3, Q4 are you going to do some sort of radical revenue recognition on that?

Hey Kris, thanks for the question. There's a few different elements of the agreement itself that are going to have different timing involved. So again we will continue to supply our current technology as part of the Phase 2 and Phase 3 trials to Voyager. Based on the Voyager communications they expect to start enrolling Phase 2 patients here in the second half of the year and then continuing to a full ramp in 2019 and similar timelines for the Q3 study as well. So shipments for that particular portion of the agreement will commence a little bit later this year. There's other elements to the agreement that without going into too much detail that we're excited about number one is that instead of only playing a role with our technology in some of these cases for Voyager, our clinical specialists will be trained on the Voyager technology and we will actually be providing case support for their technology as well. And that will be sort of an exchange for services and training and capacity and things like that. So, that's another element where we will start getting some revenue almost immediately relative to that portion of the agreement as we train up our sales team to be able to provide some of that support. Some of the other elements of the agreement focus around co-development of different opportunities so, those things depend on the timing and the priorities after our initial kick off sessions for a few of those agreements. So again with -- we can't go into too much detail or too much sort of focus on the timing. However, we're very excited to be able to do a number of different aspects whether it's software, whether it's hardware, whether it's custom cannulas for a number of different indications as well. So those will kind of rollout based on the priority that Voyager needs in their mutual pipeline.

Okay, okay thanks. Just one additional question and then I will turn it over, just regarding gross margin you talked about laser ablation dipping a little which might contribute to some gross margin increase over the next couple quarters, is that something we could expect or our new products like the aspiration device, things like that pull that back down?

You know on the gross margin side I was focused a little bit more on the overall per procedure profitability of the case and less so on gross margin when I made that comment before. So in a typical laser ablation case we typically sell only one smart frame kit at that given ASP. However, we have the cost infrastructure of a person in the room travel to the site, all the logistics around it as well. As you compare that to a bilateral deep brain stimulation where we're selling two kits in the same procedure significantly less profitable overall. However, in many cases the kit themselves is the same so the overall gross margin shouldn't be impacted too much. And I think Hal maybe you can make a couple comments there.

Yeah, and I think as far as new products go, it fully ramps up so for whatever modest margin might be represented by first units I wouldn't look for it to have that dramatic an impact on the total.

Okay and actually just one more tech question that I don't know if you can help with but do you have any more insight on when the shares might get up listed or listed on regular exchange?

Yeah, at this point we don't have any update on that side or that part of our strategy. So we're continuing to just build our business in the best possible way that we can. I think the Voyager deal we announced today is certainly a positive to that effect and supports us in a number of different ways both top line and bottom line. So we're just going to continue to focus on execution at this point and bounce back with a strong Q2.

Okay, terrific, thanks a lot guys.

Thank you. [Operator Instructions]. Our next question comes from the line of Larry Haimovitch with HMTC. Please proceed.

Good afternoon Joe, good afternoon Hal.

Hi Larry.

So my question is to Joe, what was the thing in the quarter that you particularly were most pleased with and what in the quarter would you say was the biggest disappointment or shortfall in your mind?

In the quarter it's Hal, I will start with the negative and end with the positive. I think the awareness that we've talked about in the past of our reliance on other therapies having an impact on us that you know it's not necessarily in our control but the problem solving that we need to do on occasions. And I think we saw that not necessarily with the cases that were impacted, with the concern around laser ablation. However, with the two capital deals that were sort of hung up as a result of it one of which we were pretty sure was going to be closing in Q1. So I think that that was kind of the negative side of things that it would have been excited to get that system in, get eval started and go in with first initial cases. On the positive side I think the way that we were able to respond, I think as leaders our role is to problem solve and not make excuses but rather find new ways to handle things. And I think the speed in which we put together a very mutually attractive agreement with Voyager to help fill some of the gaps that we would see in laser ablation here in 2018 I think is a testament certainly not just to me but to the entire team that really worked tirelessly to get this agreement done and do the proper diligence along the way. So I think ending on a very positive note today was an exciting step for us.

And Joe, how long did it take from when you first started negotiating with Voyager to get this agreement put together?

You know it is hard to say. I think we've always had -- we continue to have a partnership with Voyager, we always had a relationship. I would say in the past six weeks or so I think we really made an effort to outline what are the priorities and the ways that we want to work together. And moving in as they're preparing to begin their Phase 2 and Phase 3, how can we support and make their procedures more successful. And I think this clinical support side of things is exciting, it saves the company like Voyager from having to spend a good amount of money to build a clinical sales team to support the larger clinical trial and it gives us some operating leverage for the same people that are, very talented and in the room anyway so why can't we help along the way for a small fee.

Okay, and then my final question is you mentioned you are taking more ownership for the sales and marketing side of the business, has that entailed any change in personnel changing or getting -- letting people go and sales management or marketing management or whatever?

At this point we've simply been refocusing those resources on some of our key projects. Going into January of 2018 we realized that there are a couple of key and high priority sales tools that we simply don't have. So rather than focusing our time and energy and dollars for that matter really on sales management, we have got four very talented territory managers out there that know their business, something I was going to get close to anyway as my role in a small company as the CEO. So really we've been focusing some of the energies of different employees and different roles to really deliver those tools so that we can see the benefit of those in the second half. And as part of the earning script the tips and tricks and efficient workflows is a perfect example of that. Another one is our pro forma analysis that we can sort of redesign and revise the economic benefits using our technology in different hospital settings and different indications. And then there's other marketing tools as well on biopsy that we're focused on rolling out here in preparation of the second half.

Okay, great. Thank you Joe.

Thank you. We've reached the end of our Q&A session. I would like to hand the floor back over to management for closing remarks.

Thank you everyone for joining us today. I hope you can clearly see our enthusiasm for the opportunities ahead as well as our confidence in our ability to grow ClearPoint procedures, increase our installed base, become the leader in biologics and drug delivery to the brain, launch new to world guided therapy or aspiration devices, and achieve progress toward global scale and profitability. As I've said before we are fully committed to becoming an essential part of any modern neurosurgery suite and have a talented team in place with the clear purpose to make it happen. In addition to continuing to report our progress and key milestones we will be attending several upcoming investor events including the LD Micro-Cap Conference in early June. If you have interest in meeting in person at this or another event in the future please contact Matt Kreps at Darrow Associates our investor relations firm using the contact information on our press releases. They will work to ensure you are added to our meeting rosters at these or other upcoming events. Thank you very much and have a good evening.

Thank you. This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.